Independent Review: Offer Scalp Cooling With Breast Cancer Chemo

Pam Harrison

April 03, 2018

Scalp cooling before, during, and after chemotherapy is demonstrably safe and effective for the prevention of chemotherapy-induced alopecia and should be offered to all patients concerned about what can be a devastating side effect, an independent review of US-based experience says.

"When someone gets chemotherapy and they lose their hair, this is the time that their family and society recognizes that this person has cancer, and that has a huge emotional and psychological impact," Jame Abraham, MD, of the Taussig Cancer Institute, Cleveland Clinic, in Ohio, told Medscape Medical News in an email.

"Hair preservation offers some normalcy and control of the situation, so we use a scalp-cooling device for early-stage breast cancer patients who are getting chemotherapy," Abraham noted.

He added that the device is more effective with non-anthracycline-containing regimens.

The review, which was coauthored by Megan Kruse, MD, also of the Taussig Cancer Institute, was published in the March issue of the Journal of Oncology Practice.

In their review, Kruse and Abraham detail two recently published studies of scalp-cooling systems that were conducted in the United States and were published within the past year.

Both systems — the Paxman Scalp Cooling System and the DigniCap — have been approved for routine use in the United States.

The first study was the previously reported nonblinded Scalp Cooling Alopecia Prevention (SCALP) trial, in which patients with early-stage breast cancer were randomly assigned to receive scalp cooling using the Orbis Paxman Hair Loss Prevention System or to not receive scalp cooling.

All patients received either a taxane, an anthracycline-based regimen, or both agents given in the neoadjuvant or adjuvant setting.

Successful hair preservation, which was assessed after four cycles of chemotherapy, was defined as either no hair loss from baseline or less than 50% hair loss not requiring a wig.

A total of 119 patients received scalp cooling, which was administered 30 min prior to treatment, during treatment, and 90 min after treatment. Sixty-three patients, who served as control patients, did not receive scalp cooling.

At the time of interim analysis, 50.5% of the patients in the scalp-cooling group had experienced hair preservation, compared with 0 patients in the control group, the authors reported.

However, hair preservation was greater among patients who underwent taxane-based chemotherapy compared to those who received an anthracycline-based regimen (59% vs 16%).

Success also varied between participating sites — "suggesting that success in hair preservation is somewhat dependent on technique of use," Kruse and Abraham note.

Surprisingly, there were no differences in quality-of-life end points, including emotional and social functioning, anxiety, and depression, between patients who experienced hair preservation and those who lost hair despite receiving treatment or the control patients.

Adverse events included headache, chills, and skin pain and ulceration.

Nonetheless, when assessed for comfort, most patients reported that they were "reasonably comfortable" during the scalp cooling procedure.

Second Study

A second prospective study also involved women undergoing neoadjuvant or adjuvant taxane or anthracycline-based chemotherapy for early-stage breast cancer.

A total of 106 patients were randomly assigned to receive scalp cooling; 16 patients, who did not receive scalp cooling, served as a control group. The control group was purposefully small because the likelihood of hair loss in these patients exceeds 65%, the researchers point out.

Unlike the SCALP study, none of the study patients received either sequential taxane therapy, anthracycline-based treatment, or a combination of the two agents.

In this trial, the investigators used the DigniCap scalp-cooling device. Patients were treated for the 30 min prior to receiving chemotherapy, throughout chemotherapy, and for 90 min after therapy.

"A Dean scale score of ≤2 (corresponding to hair loss ≤50%) was considered successful hair preservation," the investigators note.

Of 101 evaluable patients in the scalp-cooling group, two thirds of patients experienced successful hair preservation.

"Patients in the scalp-cooling group were significantly less likely to report feeling less physically attractive as a result of their disease or treatment or being dissatisfied with their body compared with those in the control group (P = .02 and .04, respectively)," Kruse and Abraham note.

In contrast, patients who received no scalp cooling were significantly more likely to report being unhappy about their hair loss than those in the scalp-cooling group (P = .04).

Side effects were similar to those reported in SCALP study and included headache, head discomfort, skin pain, and chills, but only 3% of patients who received the scalp-cooling procedure discontinued treatment because of discomfort from the cold.

Scalp Cooling in the United States

In an accompanying commentary, Julie Nangia, MD, Baylor College of Medicine, Houston, Texas, who was the lead author of the SCALP study, points out that scalp cooling has been available in the United States for a while, but only via scalp-cooling caps.

These caps are not often used because of high out-of-pocket costs to patients and because of the labor involved in changing caps frequently during treatment to keep the scalp cold.

"Scalp-cooling devices are easier to use because they only have to be fitted once and are provided by the infusion center," Nangia points out.

Despite being easier to use, the success of scalp-cooling devices depends on three key factors, she also notes. The first is that the cap must be well fitted.

"If the cap does not fit the scalp tightly and there are gaps, the result is hair loss in the location of the gaps," she explains.

The second factor is that the temperature of the coolant inside the cap must be constant. This makes the device as cold as an ice pack, which can make it uncomfortable for patients to wear.

Success also is highly dependent on the chemotherapy regimen received, as noted in the studies.

There are several reasons why scalp cooling is not used more often in chemotherapy centers, one of which is cost.

"Infusion centers do not get to use these devices for free," Nangia points out — centers are charged a montly fee to lease the machines.

Another factor is that healthcare providers at the infusion centers have to want to offer this service to patients; scalp-cooling requires spending extra time prescribing and fitting the cap.

The procedure could also add 90 min of postcooling time to the infusion procedure, which could create bottlenecks at the chemotherapy center.

There are solutions to many of these problems, Nangia stresses, and the service is worth implementing.

"Major cancer centers across the United States are already offering this treatment, and organizations that decide not to offer this quality-of-life service may lose patients to centers that do," she warns.

"Now that we have good data regarding the safety and efficacy of scalp cooling, it should be a service oncologists discuss with and offer to all patients with breast cancer and, possibly, all patients with solid tumors," Nangia concludes.

Scalp cooling devices have been in use to prevent hair loss during chemotherapy for decades in Europe.

However, uptake of these devices has been extremely slow in the United States because of concerns that by decreasing blood flow to the scalp via vasoconstriction, less chemotherapy would be delivered to the scalp, increasing the risk for scalp metastases.

These safety concerns have not been borne out by registry data. Rates of scalp metastases among scalp-cooling recipients were reported to be vanishingly small, according to a large review published in 2005.

Dr Abraham has received honoraria from Pfizer and Genetech and speaker's fees from Pfizer. Dr Kruse has disclosed no relevant financial relationships. Dr Nangia has received research funding from Paxman Coolers Ltd.

J Oncol Pract. 2018;14:149-155. Abstract, Commentary

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